UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050180 |
|---|---|
| Receipt number | R000057155 |
| Scientific Title | Multicenter prospective observational study to clarify the current status and clinical outcome in Japanese patients who have an indication for implantable cardioverter-defibrillator (ICD) or wearable cardioverter defibrillator (WCD) |
| Date of disclosure of the study information | 2023/01/30 |
| Last modified on | 2024/01/31 09:57:36 |
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Basic information
Public title
Multicenter prospective observational study to clarify the current status and clinical outcome in Japanese patients who have an indication for implantable cardioverter-defibrillator (ICD) or wearable cardioverter defibrillator (WCD)
Acronym
TRANSITION JAPAN-ICD/WCD study
Scientific Title
Multicenter prospective observational study to clarify the current status and clinical outcome in Japanese patients who have an indication for implantable cardioverter-defibrillator (ICD) or wearable cardioverter defibrillator (WCD)
Scientific Title:Acronym
TRANSITION JAPAN-ICD/WCD study
Region
| Japan |
Condition
Condition
heart failure, ventricular fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the device introduction rate in actual clinical practice for patients with heart device indications for WCD and ICD (CRTD)
Basic objectives2
Others
Basic objectives -Others
We will investigate the reasons why devices could not be implanted in cases where the indications for ICD or WCD were met, and evaluate the differences in prognosis compared to cases where the devices were successfully implanted.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
device introduction rate
Key secondary outcomes
1.Incidence of VT/VF and presence of sudden death
2.All-cause mortality
3.Cardiovascular events (cardiovascular death, hospitalization due to heart failure, and other cardiovascular events requiring hospitalization)
4.Stroke/TIA and systemic embolism
5.Myocardial infarction and unstable angina
6.Heart failure requiring hospitalization and other cardiovascular events requiring hospitalization
7.Major bleeding
8.Clinically relevant non-major bleeding
9.Major bleeding or clinically relevant non-major bleeding
10.Cardiovascular death
11.Other deaths
12.Device complications
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Heart failure cases that meet the indication criteria for each device according to the guidelines in Japan.
<ICD primary prevention indication patients>
Patients who meet all of the following criteria:
1.Sufficient drug therapy
2.Left ventricular ejection fraction (LVEF) <=35%
3.Heart failure symptoms of NYHA functional class II or higher
<ICD secondary prevention indication patients>
Patients with LVEF <=35%, NYHA functional class II or higher heart failure symptoms, after excluding reversible factors, who meet one of the following criteria:
1.Out-of-hospital cardiac arrest with ventricular fibrillation or electric shock
2.Persistent ventricular tachycardia
3.Unexplained syncope
<WCD indication patients>
Patients who meet one of the following criteria:
1.Within 40 days after onset of acute myocardial infarction with NYHA functional class II-III heart failure symptoms and LVEF <= 35%
2.Within 90 days after coronary artery bypass grafting or percutaneous coronary intervention with NYHA functional class II-III heart failure symptoms and LVEF <= 35%
3.Within 90 days after onset of non-ischemic acute heart failure with LVEF <=35%
Key exclusion criteria
1.Patients who cannot expect to live longer than 12 months
2.Patients with recurrent VT or Vf that cannot be controlled with antiarrhythmic drugs or catheter ablation
3.Patients with drug-resistant severe congestive heart failure (NYHA class4) who are not candidates for heart transplantation, CRT, or LVAD
Target sample size
650
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Okumura |
Organization
Nihon University School of Medicine
Division name
Department of Medicine, Division of Cardiology
Zip code
173-8610
Address
30-1 Oyaguchikamityo, itabashi-ku, Tokyo
TEL
03-3972-8111
okumura.yasuo@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukitoshi |
| Middle name | |
| Last name | Ikeya |
Organization
Nihon University School of Medicine
Division name
Department of Medicine, Division of Cardiology
Zip code
173-8610
Address
30-1 Oyaguchikamityo, itabashi-ku, Tokyo
TEL
03-3972-8111
Homepage URL
ikeya.yukitoshi@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Funding Source
Organization
Medtronic Co. Boston Scientific Co.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nihon University Itabashi Hospital
Nihon University Hospital
Kanazawa University Hospital
Kawaguchi Municipal Medical Center
Kitasato University Hospital
Juntendo University Hospital
Tokyo Bay Urayasu/Ichikawa Medical Center
Dokkyo Medical University Saitama Medical Center
Fujita Health University Hospital
Shonan Kamakura General Hospital
Nihon Medical Center
Tokyo Metropolitan Hiroo Hospital
Kobe University Hospital
National Cerebral and Cardiovascular Center
St. Marianna University School of Medicine Hospital
Juntendo University Nerima Hospital
Tokyo Women's Medical University Hospital
Ogaki Municipal Hospital
Saitama Medical University International Medical Center
Jichi Medical University Hospital
Yamagata University Hospital
Kagoshima University Hospital
Hirosaki University Hospital
Chiba University Hospital
Sendai Kousei Hospital
National Hospital Organization Kanazawa Medical Center
Yamaguchi Prefectural Grand Medical Center
Saiseikai Kumamoto Hospital
Shinkoga Hospital
Showa University Hospital
Showa University Koto Toyosu Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Itabashi Hospital, Clinical Research Judging Committee
Address
30-1, Oyaguchikami-cho, Itabashi-ku, Tokyo
Tel
03-3972-8111
med.itabashi.chiken@nihon-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2023 | Year | 01 | Month | 30 | Day |
Last modified on
| 2024 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057155
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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